MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/20/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430437
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A pulsar-18 self-expandable stent system was selected for treatment.During deployment of the stent it was noticed that one of the radiopaque markers had become dislodged and travelled further down the artery.
Additional Manufacturer Narrative
Additional event description the physician intended to treat a lesion in the right popliteal artery with the complaint instrument via guided antegrade right cfa puncture and by use of 5f introducer sheath.The lesion was pre-dilated with a drug eluting balloon 4 mm.However, there was a non-flow limiting dissection at the site of balloon angioplasty so the complaint instrument was chosen.The complaint instrument was positioned and the stent was released.However, after stent deployment, the physician noticed that the distal radiopaque marker had dislodged from the delivery system and eventually flowed down the proximal segment of the ata.The complaint instrument was withdrawn.The physician stated that no unusual resistance or friction was felt during device positioning or withdrawal.The radiopaque marker was left in the patients body.There was good flow of contrast medium across the stent and this foreign body.The procedure and the events were discussed and it was decided not to intervene further and start heparin infusion.The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation confirmed that the device tip has detached from the inner shaft.All the shaft dimensions comply with the specification.In the as-returned state only about 5 mm of the inner shaft protruded from the stopper shaft.However, after cleaning about 16 mm of the inner shaft protruded from the stopper shaft, indicating a relative movement between the device shafts.It appears that due to this relative movement between the shafts, forces were applied to the device tip that eventually led to a detachment.The cause for this relative movement remains unresolved.Review of the production documentation verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause was identified.The final root cause for the reported event could not be determined.

• Brand Name: PULSAR-18 T3 4/20/90
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16779316
• Report Number: 1028232-2023-02037
• Device Sequence Number: 6709369
• Product Code: NIP
• UDI-Device Identifier: 07640130446359
• UDI-Public: (01)07640130446359(17)2311
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 430437
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11202427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown